The FDA via the DOJ has sued to get permanent injunctions against US Stem Cell, Inc. (USRM) and California Stem Cell Treatment Center/Cell Surgical Network (CSN). Both firms use an unapproved fat stem cell product in patients called stromal vascular fraction (the SVF production process is pictured at right) that the FDA indicates is generally going to be a drug product requiring premarket approval.

You can see my first quick take on these federal suits here as well as initial responses to the suits from the firms here and my Q&A with Patti Zettler on the cases here. It seems that the California case will unfold in the US District Court Eastern District of California in Irvine.

There’s still a great deal of uncertainty about what happens next. Here are what I see as the top 10 questions about these cases below.

Who wins? The biggest question is whether the FDA or the stem cell clinic firms will prevail in court. Of course, you never know, but I’d say USRM and CSN face really long odds for a variety of reasons.

Will the main defense be ‘patient rights to own stem cells’? I don’t see a clear legal basis to counter the FDA’s actions, but my impression is that the two firms both seem in their initial responses to have invoked what they see as patients’ rights to use their own cells. While there might be some scattered legal precedents for patients having rights to their own biological materials, I don’t see this defense flying. I’ve written before how we all may have fewer rights than we think to our biological materials like cells once they are removed from our bodies. See “Our bodies, not our cells?”

Will these clinic firms also cite the new Right-To-Try law in their defense?

Who will side with clinic firms if anyone? It’ll be interesting to see whether other entities take sides with the clinics. For instance, will the Goldwater Institute, which has taken a libertarian, I’d say somewhat anti-FDA stance on stem cells, support the defendants against these injunction suits? Or will conservative think-tank-like organization have to think twice given that both firms have been linked to patients allegedly losing vision? I’d lean toward predicting that Goldwater will not get involved, but we’ll see. Will other groups like Right-To-Try organizations might chime in? Nobody?

Will FDA ask for and if so get temporary injunctions? So far, no, but much may depend on the next question.

And related, will one or both clinics voluntarily shut down their offerings to patients in the interim as the suit progresses?

Will CSN lose a substantial number of its affiliates in the sense of some of those ~100 affiliates at least temporarily stopping stem cell injections or going their own way outside of CSN?

Will FDA expand on stem cell clinic oversight with substantive action against other clinics while the current cases are pending? Or is this going to be the peak of activity from Gottlieb’s FDA?

More patient suits on clinics? Will other clinic customers potentially see the federal suits as a foundation for civil suits against more stem cell clinics? There are already quite a few suits recently settled and ongoing.

Move some offerings offshore? Will either of the two firms shift some of their clinic efforts outside the U.S.? We’ve seen that before quite a few times with stem cell clinics including Celltex. If USRM or CSN, which notably both already have some international presence, shift substantial adipose stem cell offerings to other countries, will they retain an active U.S. presence doing something?

I don’t think either is going to stop unless forced to. The FDA usually wins without a fight because most companies don’t have the wherewithal to oppose them. I think the FDA counts on that. It doesn’t happen often, but the FDA does lose a case from time to time.

This year’s meeting (Rockefeller university) NYSCF featured updates on how cell therapies for diseases like Parkinson’s and macular degeneration are moving into the clinic as well as a keynote address from NIH Director Francis Collins, MD, PhD, who spoke about the promise of stem cell research and the importance of collaboration in science.

Your almost daily onslaught of reiteration of the same story of 2 small companies trying to compete and provide alternative to the pill popping treat and stay sick illustrates a clear bias. While this may secure your future position at Fox news, it is counterintuitive to both the betterment of society at large, and lines the pockets of the pharmaceutical companies that only stand to gain by delaying, hindering and postponing the inevitable.

Regenerative medicine in all its forms are and will be the future of medicine.

People want cures, not treatments.

You’d find a more moral level of journalism in promoting the future, rather than stifling it.

@John,
I don’t think we’re going to see eye-to-eye on this stuff, but that’s fine.
This is an important news story to follow and in my opinion the stakes are really high so I’m going to say what I think. I also aim to be fair and on this blog I regularly reach out to clinics and others with whom I disagree to try to include their perspectives over the 8+ years I’ve been doing this.
Paul

@John,
It’s a good question. In announcing their suits, the FDA included some rationales:
“A permanent injunction is being sought against US Stem Cell Clinic LLC of Sunrise, Florida, its Chief Scientific Officer Kristin Comella and its co-owner and managing officer Theodore Gradel for marketing to patients stem cell products without FDA approval and while violating current good manufacturing practice requirements, including some that could impact the sterility of their products, putting patients at risk. The FDA is taking this action because US Stem Cell Clinic did not address the violations outlined in a warning letter to the clinic and failed to come into compliance with the law. The FDA is seeking an order of permanent injunction requiring US Stem Cell and the individual defendants to cease marketing their stem cell products until, among other things, they obtain necessary FDA approvals and correct their violations of current good manufacturing practice requirements.

The FDA is also seeking a permanent injunction to stop California Stem Cell Treatment Center Inc., with locations in Rancho Mirage and Beverly Hills, California; Cell Surgical Network Corporation of Rancho Mirage, California; and Elliot B. Lander, M.D. and Mark Berman, M.D., from marketing to patients stem cell products without FDA approval. Berman and Lander control the operations of approximately 100 for-profit affiliate clinics, including the California Stem Cell Treatment Center. The FDA is seeking an order of permanent injunction requiring California Stem Cell Treatment Center Inc. and Cell Surgical Network Corporation and the individual defendants to cease marketing their stem cell products until, among other things, they obtain necessary FDA approvals and correct their violations of current good manufacturing practice requirements.”

SVF is, to my knowledge, not administered by way of tablets. So then how does the FDA test a batch of SVF? CGMP’s require testing by the FDA’s own admission. In fact testing alone is not even adequate according to them. BUT can anyone cite an instance where FDA testing has literally been done on the actual SVF product by before it was introduced by clinical staff into a patient? What papers have been written on this for instance by the FDA themselves?

Again. From the FDA’s website… “The main regulatory standard for ensuring PHARMACEUTICAL quality is the Current Good Manufacturing Practice (CGMPs) regulation for human PHARMACEUTICALS.”

To me, just as stem cells are not drugs, medical clinics are NOT pharmaceutical companies either; anymore than pharmaceutical companies are medical clinics. If the FDA is going to crack down on essentially a practice of medicine (which they were never mandated to do) why do they insist on applying standards to clinics that were meant solely for pharmaceutical companies?

Because they don’t have the resources to go after every one of them. They have to send an inspector, put together a warning letter, allow the clinic to respond, maybe reply to that, possibly wait on another reply from the clinic and then at some point, seek a court injunction. This process takes many months just for one company. For example, US Stem Cell’s inspection started in April of 2017. It’s been 14 months since then.

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